Product
Efficacy Report:

CELLFOOD®

Mrs.
Kim De ‘AthMr. Heinrich NolteDr. Johan Van Heerden

INTRODUCTION

Athletes
of various ages and levels of participation explore the use of ergogenic aids.
Attempts to enhance athletic performance are not new. The Olympic games date
back 2700 years, which means that seeking advantage in sport likely dates back
just as far. The winner of the 1920 Olympic 100m dash, Charlie Paddock, drank
sherry with raw eggs before the race. In 1960, the Danish cyclist Knut Jensen
died during a road race from taking amphetamines (Voy and Deeter, 1991). The use
of drugs to enhance performance is not limited to Olympic athletes only. Many
adolescent athletes experiment with anabolic steroids. Caffeine is widely used
as an ergogenic aid by runners, cyclists and triahtletes and creatine is a
popular supplement amongst university strength and power athletes (Eichner,
1997; Sinclair and Geiger, 2000) Considerable literature exists on the topic of
ergogenic aids and the athletic performance. It includes studies of the
potential performance benefits of alcohol, amphetamines, epinephrine, aspartates,
red cell reinfusion, caffeine, steroids, protein, phosphates, oxygen-rich
breathing mixtures, gelatin, lecithin, wheat-germ oil, vitamins, sugar, ionized
air, music, hypnosis, and even marijuana and cocaine (McCardle, Katch and Katch,
1991)

The ever-growing quest among
sports participants to perform better and the abundance of ergogenic supplements
makes it the responsibility of the scientific community to ensure that the
public are well informed. Knowledge is necessary to lead us into the right
direction. The prudent approach should not only focus on issues like efficacy,
health-related safety of these substances requires urgent research.

The
industry of ergogenic supplementation has become a massive commercial
enterprise. A product manufactured by Nu Science Corporation (A division of
Deutrel Industries) is currently on the market for use as ergogenic aids in
sport relying on aerobic energy provision. The product is known as Cellfood®.
The efficacy of this product and its dosage response within the context of
improved aerobic performance falls within the scope of this report.

In
cognisance of the foregoing the purpose of the study was two fold:

qFirstly, to determine whether Cellfood® has a
more positiveeffect on the
physical performance of endurance athletes than a placebo; and

qSecondly, to determine at which dosage Cellfood®
tend to be most effective.

The word ergogonic relates to
the application of a nutritional, physical, mechanical, psychological, or
pharmacological procedure or aid to improve physical work capacity or athletic
performance (McArdle et al., 1991). An ergogogenic aid, simply defined, is any
substance, process, or procedure that may, or is perceived to, enhance
performance through improved strength, speed, response time, or the endurance of
the athlete. Another area of interest in ergogenic aids is to hasten recovery.
The nature of the action of any supposed ergogenic aid may be elicited through
the following:

qDirectly act on muscle fiber;

qCounteract fatigue products;

qSupply fuel needed for muscular contraction;

qAffect the heart and circulatory system;

qAffect the respiratory system; and

qCounteract the inhibitory affects of the
central nervous system on muscular contraction and other functions

Frequently ergogogenic aids are
thought of only as pharmacological agents that may be consumed to give the
athlete an advantage. Pharmacological agents constitute only one of several
classes of ergogenic aids. Others include nutritional (carbohydrates, proteins,
vitamins, minerals, water, and electrolytes), physiological (oxygen, blood
boosting, conditioning, and recovery procedures), psychological (hypnosis,
suggestion, and rehearsal), and mechanical (improved body mechanics, clothing,
equipment, and skill training) components.

In its broadest sense, one
could call anything that can be related to an improvement in work or performance
an ergogenic aid. Ergogenic aids affect different people differently, as might
be expected. For some, studies show a positive influence on work performance and
for others, no affect whatsoever. What might prove effective with the athlete
may prove inconsequential to the nonathlete and vice versa. Certain ergogenic
aids may influence a person’s endurance performance but may have little or no
effect on activities requiring short bursts of strength and power (Fox and
Bowers, 1993; Williams, 1983).

METHODS AND PROCEDURES OF THE STUDY

Subjects

Forty-five
marathon runners between the ages of 20-51 years (mean age = 38,4 ±
8.2 years) volunteered to take part in the study. All of the participants were
members of marathon clubs in and around Pretoria. They were all briefed on the
nature of the research project and possible risks involved. They were not
allowed strenuous training the day before each test.

The
following specific exclusion criteria were applied:

a)haematology results not within the normal physiological limits

b)taking any other ergogenic supplement or aid

c)medication usage

Study Design

The
primary aim of the study was to determine the efficacy of Cellfood® as an
ergogenic aid for endurance athletes. In order to reach this goal a pre-test –
post-test, experimental design, was adopted for the study. Subjects were
randomly assigned to one of two groups.

Each of
these groups underwent an intervention period of four weeks. After each
four-week period the subjects stopped taking the supplementation and underwent a
two-week wash out period during which they took no supplementation. The dosage
taken for the product varied throughout the whole study depending on the cycle
in which the product or placebo was taken.

Cycle
1

Cycle 2

Cycle 3

Group

Product

Dosage

Product

Dosage

Product

Dosage

A

Cellfood

28ml

Cellfood

39.2ml

Cellfood

44.8ml

B

Placebo

28ml

Placebo

39.2ml

Placebo

44.8ml

VARIABLES MEASURED

The following variables were measured:

1.Anthropometry

qStature

qBody mass

2.Haematology

qFull blood count

qFerretin values

qFasting glucose

qBlood type

3.Oxygen utilization and related spirometry

4.Pulse oximetry

5.Capillary blood lactate concentrations

6.Rate of perceived exertion

7.Heart rate

Stature

The
stature was measured with a calibrated stadiometer. The subject stood barefoot,
feet together and heel, buttocks and upper part of the back touching the gauge,
with the head in the Frankfort plane, not necessarily touching the gauge. The
Frankfort plane was considered as the orbital (lower edge of the eye socket)
being in the same horizontal plane as the tragion (notch superior to the tragus
of the ear). When so aligned the vertex was the highest point on the skull. The
measurement was taken to the nearest 0.1 cm at the end of a deep inhalation

Body
Mass

Body
mass was measured using a Detecto beam balance scale. The measurement was taken
to the nearest 0,1 kg, with the subject barefoot, clothed only in appropriate
running clothes, and taking care that the:

qScale was reading zero;

qSubject stood on the centre of the scale
without support;

qSubject’s weight distribution was even on
both feet; and

qSubject’s head was held up and the eyes
looked directly ahead.

Figure
1: Detecto scale and stadiometer

Haematology

The
blood analysis was performed by a professional pathology laboratory namely
AMPATH (a division of Du Buisson and Partners pathologist).

The
following reference ranges were utilized:

Haemoglobin14.0 – 18.0 g/dL

Red
blood cell count4.60 – 6.00 10^12/L

Hematocrit42 – 52%

Fasting
glucose3.5 – 6.0 mmol/L

Ferretin22 - 322 ng/mL (men)

Ferretin22-291 ng/mL (women)

Figure 2: Copy of haematology
pathologist report

Maximal
Oxygen Uptake

The
maximum oxygen uptake (V02 max) was determined through direct/ open
circuit spirometry, using a Schiller CS-100 gas analyser and a Quinton motorized
treadmill (model 24-72). The gas analyser was calibrated before each test with
the appropriate gas mixtures supplied by Air Products. The tests were conducted
within an air-conditioned laboratory at a temperature of 20°C
and barometric pressure of more or less 655 mmHg. The treadmill protocol started
at a running speed of 8km/h and the elevation remained constant at 2% throughout
the test. The speed was increased every two minutes until a running speed of
16km/h was reached. After this point, the treadmill speed was increased with 1
km/h every two minutes until exhaustion. The athletes were verbally encouraged
and the tests were terminated when the athletes could not maintain the running
speed.

Gas
values were sampled every ten seconds. The following gas analysis values were
recorded during the V02 max test, presented in their abbreviated and
defined format as defined by the Schiller CS 200 user manual:

qVT: Tidal volume- The volume of air actually
breathed per breath in ml.

qVE: Minute ventilation- The volume of air taken
into or exhaled from the body in one minute. This is conventionally expressed at
body temperature, saturated with water at atmospheric pressure (BTPS)

qV02: The amount of oxygen extracted
from the inspired gas in a given period of time, expressed in millilitres or
liters per minute, standard pressure and temperature, dry (STPD). This can
differ from oxygen consumption under conditions in which oxygen is flowing into
or being utilized from the body’s stores. In the steady-state, oxygen uptake
equals oxygen consumption

qV02 relative: V02
expressed in ml/kg/min.

qVC02: The amount of carbon dioxide
(C02) exhaled from the body into the atmosphere per unit time,
expressed in millilitres or liters per minute, STPD. This differs from C02 production
rate under conditions in which additional C02 may be evolved from the
body stores or C02 is added to the body stores. In steady state, C02
output equals C02 production rate. In rare circumstances, appreciable
quantities of C02 can be eliminated from the body as bicarbonate via
the gastro-intestinal tract or by haemodialysis.

qRQ: The respiratory quotient is the rate of
carbon dioxide production to oxygen consumption. This ratio reflects the
metabolic exchange of gasses in the bodies’ tissue and is dictated by
substrate utilization.

qVE/V02: Respiration equivalent for
oxygen is the actual ventilation against absolute oxygen uptake. This parameter
indicates how much air (l) must be inhaled to obtain a liter of oxygen.

qVE/VC02: Respiration equivalent for
carbon dioxide is the actual ventilation against absolute carbon dioxide
exhaled. This parameter indicates how much air (l) must be exhaled for one liter
of carbon dioxide to be expelled. The smaller this parameter the better the
carbon dioxide exchange efficiency.

qet02:End tidal expired oxygen partial pressure (mmHg) is the partial oxygen
pressure (P02) determined in the respired gas at the end of an
exhalation. This is typically the lowest Po2 determined during the alveolar
portion of the exhalation

qetC02: End tidal expired carbon
dioxide partial pressure (mmHg) is the partial carbon dioxide pressure (PC02)
of the respired gas determined at the end of an exhalation. This is commonly the
highest PC02 measured during the alveolar phase of exhalation

Figure
3: Athlete connected to gas analyser, performing a test

Figure
4: Athlete connected to gas analyser, performing a test

Figure 5: Schiller CS 100 (Gas Analyser)

Capillary
Blood

Capillary
Blood Lactate Concentration

Incremental
capillary blood lactate measurements were taken during the treadmill test by
using an Accurex BM lactate meter (Roche diagnostics). This required a puncture
of the fingertip to obtain a peripheral blood sample. These samples were taken
at the end of each two-minute stage during the treadmill test. The values were
reported in mmol/l.

Figure
6: Accurex BM Lactate Meter

Pulse
Oximetry

Incremental
haemoglobin oxygen saturation levels were taken using a Datex- Ohmeda TuffSat
hand-held pulse oximeter. The measurements were taken using a finger probe (ClipTip
-sensor). These measurements were taken at the end of each two-minute stage
directly after the blood samples were taken, expressed as a percentage.

Figure
7: Datex-Ohmeda Tuffsatt hand-held pulse oximeter

Rate
of Perceived Exertion

The
original Borg scale (6-20) was used to determine the perceived rate of exertion
(RPE) for each subject (Borg, 1973). They were asked to indicate their perceived
level of exertion on the scale at the end of each two-minute stage during the
treadmill run.

Heart
Rate

Heart
rates were recorded using a Polar Accurex Plus heart rate monitor. Heart rates
were recorded continuously during the entire test.

Figure
8: Polar Accurex Plus heart rate monitor

Summary
of variables measured

All the
variables mentioned before have an influence on the performance of an endurance
athlete; some contribute more to the achievement of success than others. If one
had to emphasize a few of these, one could single out the following:

·Haematology

·Haemoglobin saturation

·Blood lactate accumulation

·Gas analysis (V02 max)

All
the above-mentioned variables affect the performance of an endurance athlete, no
matter what their conditioning level or potential for the sport. Next we will
have a look at how Cellfood influenced these variables during our experiment

RESULTS AND DISCUSSION

Haematology
(Figure 1-8 and Table)

Iron (ferretin) has two very important
exercise related functions. Firstly, about 80% of the iron in the body is in
functionally active compounds combined with haemoglobin in red blood cells. This
iron-protein compound increases the oxygen carrying capacity of the blood about
65 times. Secondly, iron (about 5%) is a structural component of myoglobin,
which aids in the transport and storage of oxygen within muscle cells (McCardle,
Katch and Katch, 1991) About 20% of the iron in the body is found in the liver,
spleen and bone marrow in the forms of hemosiderin and ferretin. Since ferretin
is present in the plasma it is an excellent indicator of the iron stores of the
body (Meyer and Meij, 1996) Normal iron levels are crucial in preventing
conditions such as iron deficiency anaemia (McArdle et al., 1991). Iron
deficiency anaemia is characterized by sluggishness, loss of appetite and a
reduced capacity for sustaining even mild exercise (McArdle et al., 1991).
Keeping the above-mentioned in mind one can see why it would be beneficial if
either one of the products would be effective in increasing the iron stores in
the body.

Haemoglobin is essential for the transport
of both oxygen and carbon dioxide. Haemoglobin also serves the important
function of acting as an acid base balance buffer (Meyer and Meij, 1996). Oxygen
is not very soluble in fluid substances, only about 0.3ml gaseous oxygen
dissolves in each 100ml of plasma. Although this is a very small amount it
serves an important physiological purpose in establishing the P02 of
the blood and the tissues. This pressure plays a role in the regulation of
breathing and also determines the loading and release of oxygen from haemoglobin
in the lungs and tissues respectively (McCardle, Katch and Katch, 1991). This
means that the majority of oxygen is carried through the body in chemical
combinations. This takes place with the help of haemoglobin. Haemoglobin
contributes to about 34% of the volume of a red blood cell. Haemoglobin
increases the blood’s oxygen carrying capacity with about 65 to 70 times
compared to that of the dissolved oxygen in the plasma. Thus for each liter of
blood about 197ml of oxygen are carried through the body in chemical combination
with haemoglobin (McCardle, Katch and Katch, 1991) Men have approximately 15-16
g of haemoglobin in each 100ml of blood. The blood’s oxygen carrying capacity
changes only slightly with normal variations in haemoglobin values, while a
significant decrease in iron content of the red blood cells will lead to a
decrease in the blood’s oxygen carrying capacity and corresponding reduced
capacity for sustaining even mild aerobic exercise (McCardle, Katch and Katch,
1991).

It is possible to determine the amount of
red blood cells per volume unit of blood. The average count for adults males
vary from 4.6 to 6.2 x 10 12 /l blood and adult woman from 4.2 to 5.4
x 1012 /l. The red cell count is higher in newborn babies as well as
people who live at high levels above sea level. The values could also be higher
or lower during certain illnesses (Meyer and Meij, 1996). Three of the main
functions of red blood cells include the following: firstly they are responsible
for the transport of oxygen from the lungs to the tissue and transport of carbon
dioxide from the tissue to the lungs. Secondly, red blood cells help to maintain
pH homeostasis within the body. Thirdly, red blood cells contribute just as much
to the viscosity of the blood as plasma proteins.

Hematocrit refers to the contribution of
cells to a certain volume of blood. White blood cells contribute less than 0.08%
to the hematocrit. The contribution of cells is higher in newly born infants and
people who live at high levels above sea level as well as people that is
dehydrated and people with high red cell counts. The values are lower in people
who suffer from anaemia (Meyer and Meij, 1996).

After using Cellfood at a
dosage of 15 drops once a day the athletes showed increases in all
of the above mentioned haematology variables. It is important to
note that all the values remained within the physiological limits
although there were increases.. All the mentioned changes
(increases) will aid the athlete’s in their ability to transport
oxygen through their bodies to their working muscles.

Figure 1: Ferretin Values

Figure 2: Ferretin Values - Relative
Change

Figure 3: Haemoglobin Values

Figure 4: Haemoglobin Values –
Relative Change

Figure 5: Red Blood Cell Values

Figure 6: Red Blood Cells Values –
Relative Change

Figure 7: Haematocrit Values

Figure 8: Haematocrit Values –
Relative Change

Haemoglobin
Saturation (Figure 9and Table II)

One
molecule of Hb is capable of combining with maximally four molecules of
oxygen. In terms of amount this turns out to be 1.34ml of oxygen per gram of
Hb. Thus one gram of Hb becomes saturated with oxygen when it combines with
1.34ml of oxygen. At rest and at sea level, about 15 grams of Hb are present
in every 100ml (for males, 16 grams per 100ml and for females, 14 grams per
100ml). Therefore under these conditions, the oxygen capacity of Hb is 15 x
1.34 =20.1ml O2/ 100ml blood, or 20.1 volumes percent (volumes
percent in this case means millilitres of O2 per 100ml blood). With
exercise the Hb concentration of blood increases anywhere from 5 – 10%. This
is due, at least in part, because fluid shifts from the blood into the active
muscle cells, and hemoconcentration results. A 10% hemoconcentration during
exercise means that there will be about 16.5 grams of Hb per 100ml of blood
instead of 15 grams. The oxygen capacity of Hb would in this case increase
from 20.1 to 22.1 volumes percent, a definitely advantageous change. The last
important concept regarding Hb is the percent saturation of Hb with oxygen.
The percentage saturation of haemoglobin with oxygen (%SO2) was
measured incrementally throughout the treadmill tests. This values relates the
amount of oxygen actually combined with haemoglobin (content) to the maximum
amount of oxygen that could be combined with haemoglobin (capacity):

%SO2
= (O2 content of Hb/ O2 capacity of Hb) x 100

A
saturation of 100% means that the oxygen actually combined with the Hb is
equal to the oxygen capacity of Hb. The use of %SO2 takes into
account individual variations in Hb concentrations (Fox et al., 1993).

Cellfood had the most
beneficial influence on the saturation of haemoglobin (with
oxygen) while taken at a dosage of 17 drops once a day. Cellfood
increased the saturation levels at all the running speeds during
the treadmill test. Again this is beneficial to the athlete
since more oxygen is available for transport through the body

Figure 9: Haemoglobin Saturation Values – Relative
Change

Blood Lactate Accumulation (Figure 6 and Table III)

Lactate
is one of the products of glycolysis. It is both produced and used by the
muscles. It’s rate of production increases as the exercise rate increases
and as more carbohydrates is used to fuel exercise (Noakes, 1992) Glycolysis
refers to the process where carbohydrates are broken down to pyruvic acid or
lactic acid (Meyer and Meij, 1996). Lactic acid does not necessarily
accumulate at all levels of exercise. During light and moderate exercise the
energy demands are adequately met by reactions that use oxygen. In biochemical
terms, the ATP for muscular contraction is made available predominantly
through energy generated by the oxidation of hydrogen. Any lactic acid formed
during light exercise is rapidly oxidized. As such, the blood lactic acid
levels remains fairly stable even though oxygen consumption increases. Lactic
acid begins to accumulate and rise in an exponential fashion at about 55% of
the healthy, untrained subject’s maximal capacity for aerobic metabolism.
The usual explanation for the increase in lactic acid is based on the
assumption of a relative tissue hypoxia (lack of adequate oxygen) in heavy
exercise (McCardle, Katch and Katch, 1991). For this reason it would be
beneficial to the athlete if Cellfood could help the oxygen supply to the
muscle and surrounding tissue, preventing or rather delaying the onset of
hypoxia due to increased exercise intensity. An untrained individual who
fasted overnight and who has a sample of blood collected in the morning from
an arm vein before any exercise, has a lactate level ranging from 0.44 to 1.7
mmol/L. Martin and Coe (1997) also found the equivalent of 0.3 to 0.6 mmol/L
to be true for trained individuals, providing that they are not over trained.
Within an hour after an intensive training session during which blood lactate
levels reach the highest achievable values (15mmol/L), muscle lactate levels
will return to normal (Noakes, 1992). Lactic acid produced in working muscles
is almost completely dissociated into H+ and lactate within the range of
physiological pH, which contributes to the metabolic acidosis (Hirokoba,
1992).

Cellfood was very
effective in decreasing lactate values during the test. The most
effective dosage was at 15 drops once a day. Cellfood made for
lower lactate values at all the comparative running speeds
during the test. Lower lactate values would definitely be
beneficial to the endurance athlete. Decreases ranged between 10
and 25%.

Figure 10: Lactate Values -Relative Change

Gas Analysis (V02 max)

qV02 max (absolute)

As
can be expected there is an increase in oxygen consumption with anincrease in running speed. This occurs as follows. As exercise increase
in intensity, the muscles recruit more myofibrils to produce ever more
powerful contractions. This demands increased amount of energy, and this in
turn demands a greater oxygen supply. Thus V02 max is the maximum
rate of oxygen flow and is usually expressed relative to body weight (millilitres
of oxygen per kilogram of body weight per minute) (Noakes, 1992). Higher
oxygen consumption values would be beneficial to the endurance athlete by
increasing the amount of oxygen utilized by the body to supply energy to the
working muscles. V02 max is to a great extent determined by
genetics and only a small percentage increase is possible by the correct
training methods.

The working of Cellfood
on various systems in the body made it possible to detect an
increase in the absolute V02 max of the athletes. The
most effective dosage again was that of 17 drops a day, which
resulted in an increase of 5%.

Figure 11: Absolute
Oxygen Consumption – Relative Change

PRODUCT COMPARISON REGARDING DOSAGE EFFICACY

Summary: CellfoodÒ

It is clear
that a certain pattern exists regarding the optimal dosage for performance
when using the Celfood® product. Concerning the haematology and the lactate
accumulation CellfoodÒ
was the most effective using a dosage of 39.2ml(35 drops once per day) while CellfoodÒ
showed the best results in all the other variables when the subjects took a
dosage of 44.8ml (40 drops once per day). This indicates that Cellfood® is
more effective when it is administered at the higher of the tested dosages.
Further studies could possibly answer the question if Cellfood® would reach
an upper “threshold” dosage where after the efficacy would show a decline.
In conclusion it would be best for athletes to make use of Cellfood® at a
higher dosage to ensure better performance.

GLOSSARY OF TERMS

METS: Thisterm is used as an equivalent for maximal oxygen uptake. One MET is
equal to 3.5ml/02/kg/min. This value is often used to determine a
person’s relative working intensity.

RR: Respiration rate
refers to the number of breaths taken per minute. Respiration rate multiplied
by tidal volume is an indication of a person’s minute ventilation.

VT: This refers to
tidal volume, which is an indication of the volume of air inspired per breath
in ml. or liters.

VE: This refers to the
minute ventilation, which is an indication of the amount of air that is
ventilated per minute (ml. or liters)

V02: The
maximum amount of oxygen that the body can take in, use and transport through
the body to the working muscles. This is an accurate predictor of a person’s
potential to perform well at endurance events that make use of the aerobic
energy system in the body.

VC02: The
amount of carbon dioxide that is exhaled from the body per minute.

RQ: The respiratory
quotient refers to the rate of carbon dioxide production to that of oxygen
consumption. This value is a good indication of a person’s work rate and
also indicates what type of substrate is being utilized as energy, fat,
protein or carbohydrates.

VE/V02: The
breathing equivalent for oxygen indicates the amount of air that needs to be
inhaled to obtain one liter of oxygen. The lower this value during maximal
effort the better the person’s ability is to extract oxygen from ambient
air.

VE/VC02: The
breathing equivalent for carbon dioxide indicates the amount of air that needs
to be exhaled for one liter of carbon dioxide to be expelled. The lower this
value the better the person’s ability to rid the body of excess carbon
dioxide.

et02: End
tidal expired oxygen partial pressure (mmHg) is the partial oxygen pressure
(P02) determined in the respired gas at the end of an exhalation.

etC02: End
tidal expired carbon dioxide partial pressure (mmHg) is the partial carbon
dioxide pressure (PC02) of the respired gas determined at the end
of an exhalation.